Efficacy and Safety of Colistin Based Antibiotic Therapy for Multidrug Resistant Gram Negative Infections in Pediatric Intensive Care Unit
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hemodynamic Parameters Measurement ,respiratory rate.
研究概览
简要总结
To evaluate the efficacy and safety of antibiotic combinations containing Colistin in the treatment of children with multidrug-resistant gram negative infections admitted in the pediatric surgery intensive care unit.
The main outcome measure is clinical and microbiological responses to therapy.
The secondary outcome is the occurrence of adverse events during Colistin combination treatment.
详细描述
Patients and Methods
Design of the study:
- Prospective, Randomized, interventional study.
Setting:
- The study will be conducted in the pediatric surgery intensive care unit in Children's Hospitals, Ain Shams University, Cairo, Egypt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children with culture proven nosocomial infections due to multidrug resistance gram-negative organisms
排除标准
- •Patients who started on Colistin treatment outside the pediatric surgery intensive care unit and transferred to the unit afterward will be excluded.
- •Patients who will receive <6 doses of intravenous Colistin will be excluded.
- •Patients received Imipenem or Colistin-Imipenem compination as empirical antibiotic.
研究组 & 干预措施
Montherapy
Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours
干预措施: Tienam 500 (Drug)
Montherapy
Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours
干预措施: Infusion (Device)
Combination
Thirty patients will receive IV Colistin in dosages of 50,000-75,000 IU/kg/day in three divided doses, infused IV in 10mL normal saline over 30 minutes with IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬.21,22,24 Colistin formulation consists of 2 million IU per vial.
干预措施: Tienam 500 (Drug)
Combination
Thirty patients will receive IV Colistin in dosages of 50,000-75,000 IU/kg/day in three divided doses, infused IV in 10mL normal saline over 30 minutes with IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬.21,22,24 Colistin formulation consists of 2 million IU per vial.
干预措施: Infusion (Device)
结局指标
主要结局
Hemodynamic Parameters Measurement ,respiratory rate.
时间窗: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the respiratory rate.
Hemodynamic Parameters Measurement ,heart beating rate.
时间窗: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the heart beating rate.
Hemodynamic Parameters Measurement ,partial oxygen saturation pressure
时间窗: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the partial oxygen saturation pressure
Hemodynamic Parameters Measurement and Septic Markers, serum lactate
时间窗: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the serum lactate
Hemodynamic Parameters Measurement ,blood pressure
时间窗: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the blood pressure
Hemodynamic Parameters Measurement ,serum creatinine
时间窗: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the serum creatinine
Hemodynamic Parameters Measurement ,body temperature
时间窗: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the body temperature
次要结局
未报告次要终点
研究者
Ahmed Saeed Attia Mancy
Pharmacist
Ain Shams University